MAUDE Adverse Event Report: ALLERGAN (KELLER) KELLER FUNNEL2 (5PK); KIT, SURGICAL INSTRUMENT, DISPOSABLE

Catalog Number	HA-005
Medical Device Problem Codes	Improper or Incorrect Procedure or Method (2017); No Apparent Adverse Event (3189); Inadequate Lubrication (4057)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/15/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Clarification to d4 device information: lot number was provided as 22f09c, but the information is not populating.Manufacturing and expiration dates for this lot number have been added to the record.Further information from the reporter regarding event, product, or patient details has been requested.No additional information is available at this time.Reason for reoperation: n/a; "lubrication never was activated".
Event or Problem Description
Healthcare professional reported "lubrication never activated" and "didn't have the lubrication gel" for two keller funnels.Patient contact did not occur.The affected devices have been discarded.
Additional Manufacturer Narrative
Additional, changed, and/or corrected data: b5, h6.
Event or Problem Description
Upon further review by abbvie medical safety, it has been determined that the reported event of "lubrication never activated" and "didn¿t have the lubrication gel" for two keller funnels is considered non-serious.The keller funnels were discarded and not used with any patient.There was no report of user or patient harm.Considering the device is not required and a backup device could be obtained, if the event were to recur, it would not be likely to result in serious injury or death.This record is no longer reportable to the fda and will be un-reported.
Event or Problem Description
Healthcare professional reported "lubrication never was activated" and "lubrication gel was not observed" in a keller funnel.Device was "discarded and not used with any patient".Healthcare professional was using the keller funnel after the expiration date of the device.
Additional Manufacturer Narrative
Correction to b5 description of event, h6 adverse event problem: though a serious injury has not occurred in relation to this report of lack of lubricity, abbvie will conservatively consider this a reportable malfunction.A review of the device history record has been completed.No deviations or non-conformances noted.Reason for reoperation: n/a; "lubrication never was activated"; keller funnel used after its expiration date.

• Brand Name: KELLER FUNNEL2 (5PK)
• Common Device Name: KIT, SURGICAL INSTRUMENT, DISPOSABLE
• Manufacturer (Section D): ALLERGAN (KELLER); 2525 dupont drive; irvine CA 92612
• Manufacturer (Section G): ALLERGAN (KELLER); 2525 dupont drive; irvine CA 92612
• Manufacturer Contact: terry ingram ; 2525 dupont drive; irvine, CA 78759 ; 8479366324
• MDR Report Key: 21031416
• Report Number: 3011299751-2024-00195
• Device Sequence Number: 17173838
• Product Code: KDD
• UDI-Device Identifier: 10888628043725
• UDI-Public: 10888628043725
• Combination Product (Y/N): N
• Initial Reporter State: PR
• Initial Reporter Country: US
• PMA/510(K) Number: 510(K)EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/21/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 06/17/2024
• Device Catalogue Number: HA-005
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/04/2024
• Supplement Date Received by Manufacturer: 01/07/2025; 02/21/2025
• Initial Report FDA Received Date: 12/28/2024
• Supplement Report FDA Received Date: 01/07/2025; 02/21/2025
• Date Device Manufactured: 06/17/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown